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Table 1 Demographics and clinical characteristics at baseline

From: Efficacy and safety of HLX01 in patients with moderate-to-severe rheumatoid arthritis despite methotrexate therapy: a phase 3 study

 

HLX01

(n = 183)

Placebo

(n = 92)

Age, years, mean (SD)

49.1 (11.8)

47.9 (11.0)

Female, n (%)

153 (83.6)

80 (87.0)

Chinese, n (%)

183 (100)

92 (100)

BMI, kg/m2, mean (SD)

22.7 (3.0)

22.2 (3.2)

Duration of disease, months, mean (SD)

88.4 (87.7)

75.5 (91.5)

RF positive, n (%)

167 (91.3)

86 (93.5)

Anti-CCP antibody positive, n (%)

175 (95.6)

81 (88.0)

Anti-CCP antibody negative, n (%)

7 (3.8)

9 (9.8)

SJC, mean (SD)

11.8 (5.9)

11.4 (7.3)

TJC, mean (SD)

20.9 (13.1)

19.5 (12.7)

CRP, mg/l, mean (SD)

16.9 (21.0)

22.2 (27.6)

ESR, mm/h, mean (SD)

39.2 (24.6)

43.4 (28.1)

DAS28-CRP, mean (SD)

5.5 (0.9)

5.4 (1.0)

DAS28-ESR, mean (SD)

6.1 (1.1)

6.1 (1.1)

HAQ-DI score, mean (SD)

1.4 (0.7)

1.5 (0.7)

PtAAP-VAS score, mean (SD)

60.5 (21.3)

58.2 (21.5)

  1. Anti-CCP anti-cyclic citrullinated peptide, BMI body mass index, CRP C-reactive protein, DAS28 disease activity score of 28 joints, ESR erythrocyte sedimentation rate, HAQ-DI Health Assessment Questionnaire-Disability Index, PtAAP-VAS Patient’s Assessment of Arthritis Pain-Visual Analogue Scale, RF rheumatoid factor, SD standard deviation, SJC swollen joint count, TJC tender joint count